Needleless microprotrusion elastoplast system

ABSTRACT

A needleless microprotrusion system for infusion of a medicament into a patient includes a plurality of microprotrusions having a length sufficient to penetrate a stratum corneum of the patient. A chemodenervating agent is disposed in a microprotrusions in a substrate is provided for supporting the microprotrusion and conforming the microprotrusions to a selected patient body part in order to enable uniform penetration of the microprotrusions into the corneum.

The present invention is generally directed to a delivery system for amedicament and is more particularly directed to a needlelessmicroprotrusion system for infusion of a medicament into a patient.

Still more particularly, the present invention relates to a novel methodof administering chemodenervating agents in a controlled andreproducible manner so as to confine effectiveness of the agent to agiven region while minimizing the effects of the agent on adjacenttissue.

Chemodenervating agents such as, for example, botulinum toxin, has beenfound effective for the treatment of hyperhidrosis and otherdermological indications, such as glabellar lines and brow furrow.Current therapies include topicals, that is, for example,antiperspirants, creams and systemic products. All to often these areshort acting and/or ineffective.

As noted, a significant advantage in ameliorating sweating and removingwrinkle lines has been achieved through the action of botulinum toxininjections. While this specific treatment is revolutionary andefficacious, the patient is unfortunately placed under significantamount of duress and discomfort due to need to administer multipleinjections.

In addition, since each injection represents a possibility forinfection, the injections are typically spaced apart from one another,which results in peak and valley concentrations of the medicament.

The epithelia layer of the skin, also referred to as the epidermis, is apart of the skin which provides a barrier against penetration andconsists of four layers. These layers are an outermost layer called thestratum corneum and three underlying layers called the stratumgranulosum, the stratum malpighii, and the stratum germinativum.

The present invention provides for a system for intradermaladministration of neurotoxins in the treatment of hyperhidrosis, skinwrinkles including facial lines.

SUMMARY OF THE INVENTION

The present invention provides for a needleless microprotrusion systemfor infusion of a medicament into a patient which includes a pluralityof microprotrusions having a length sufficient to penetrate a stratumcorneum of the patient and a chemodenervating agent disposed on or inthe microprotrusions.

A substrate is provided for supporting the microprotrusions with thesubstrate. The substrate features a shape for conforming to a selectedpatient body part in order to enable uniform penetration of themicroprotrusions into the stratum corneum.

In one embodiment of the present invention, two pluralities ofmicroprotrusions are provided with one plurality of microprotrusionsdisposed on one side of the substrate and another plurality ofmicroprotrusions disposed on another side of the substrate.

A preferred shape for this embodiment includes a substrate sized forpositioning within the palm of a patient and preferably thechemodenervating agent in accordance with the present inventioncomprises botulinum toxin, preferably type A.

A method in accordance with the present invention utilizing thisembodiment basically includes the steps providing a substrate having ashape for conforming to the palm of a patient with the substrate havingmicrointrusions disposed on opposite sides of the substrates. Thesubstrates have a length sufficient to penetrate the stratum corneum ofthe patients' palm.

A chemodenervating agent is provided for delivery by themicroprotrusions and the patent is instructed to dispose the substrateon one palm and press the other palm against the substrate in order toeffect simultaneous delivery of the chemodenervating agent into bothpalms.

In another embodiment of the present invention a substrate is size andshaped for conforming to a patients armpit and in yet another embodimentof the present invention the substrate is sized and shaped forapplication to a glabellar region of the patient.

In addition, an adhesive disposed on the substrate may be provided fortemporarily adhering the substrate to a patients' skin at a selectedlocation and is suitable for receiving the size and shape of thesubstrate.

To further enhance uniform penetration of the microprotrusions into thestratum corneum, the substrate is preferably flexible.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention may be more clearly understood with reference tothe following detailed description in conjunction with the appendeddrawings, of which:

FIG. 1 is a side view of one embodiment of the present inventiongenerally showing two pluralities of microprotrusions disposed onopposite sides of a substrate;

FIGS. 2 and 3 illustrate the use of the system shown in FIG. 1 whichincludes a substrate sized for positioning within the palm of a user;

FIGS. 4-5 show other embodiments of the system in accordance with thepresent invention utilizing a single plurality of microprotrusions and asubstrate for supporting the microprotrusions and having a shape forconforming to a selected body part along with an adhesive fortemporarily adhering a substrate to a patients' skin;

FIGS. 6 and 7 illustrate application of the embodiment shown in FIGS. 4and 5;

FIG. 8 shows an alternative embodiment of the present invention in whichthe substrate is sized and shaped for fitting the fossa axillaris(armpit) of a patient;

FIG. 9 shows and alternative embodiment of the present invention inwhich the substrate is sized and shaped for positioning against a users'palm and fingers;

FIG. 10 shows an alternative embodiment of the present invention inwhish the substrate is sized and shaped for positioning against a users'sole and toes; and

FIG. 11 is an enlarge view of the microprotrusions shown in FIGS. 1 and4.

DETAILED DESCRIPTION

With reference to FIG. 1, there is shown a needleless microprotrusionsystem 10 in accordance with the present invention for infusion of amedicament (not shown) into a patient, also not shown in FIG. 1.

The system 10 generally includes two pluralities 12, 14 ofmicroprotrusions 16, 18 disposed on opposite sides 20, 22 of a substrate24.

The microprotrusions 16, 18 may be of any suitable size andconfiguration and formed from a metal, preferably stainless steel, orother inert material that are directly embedded into the substrate 22which is preferably an inert platform such as silicone, orpolypropylene. With the proper selection of materials, themicroprotrusions and substrate may be formed unitarily.

A chemodenervating agent, preferably botulinum toxin, is disposed on themicroprotrusions 16, 18 and covered with a removable liner 32 in aconventional manner, said liner being removable for exposing themicroprotrusions 16, 18 for use.

As more clearly shown in FIGS. 2 and 3, the substrate 22 is sized andshaped for conforming to a patients' palm 36 which enables a method inaccordance with the present invention as illustrated in FIG. 3 in whicha patient, following instructions, disposes the system 10 in one palm 36and press another palm 38 against the system 10 in order to effectsimultaneous delivery of the chemodenervating agent into both palms 36,38.

This method for delivering the medicament is suitable for treatment ofhyperhidrosis. Preferably, the substrate is flexible for enablinguniform penetration of the microprotrusions 16, 18 into the patients'palms 36, 38 respectively. Microprotrusions suitable for use in thepresent invention are described in U.S. Pat. No. 6,322,808 which is tobe incorporated herewith in its entirety for a description of suitablemicroprotrusions 16, 18 and substrates 24.

With reference to FIGS. 4 and 5, there are shown alternative embodiments44, 46 in accordance with the present invention which further includeexposed portions 48, 50 respectively which include an adhesive fortemporarily adhering the substrate portions 48, 50 to a patient, seeFIGS. 6 and 7 respectively which illustrate application of theembodiment 44 for removing wrinkles adjacent a patients' eye and in aglabellar region of the patient.

In another embodiment 56 of the present invention as illustrated in FIG.8 in which a substrate 58 is sized and shaped for fitting and conformingto a patients armpit 60.

FIGS. 9-10 are alternative embodiments 64, 66 illustrating substrates68, 70 respectively, which are sized and shaped for positioning againsta palm 74 and fingers 76 of a user and for positioning against a sole 80and toes 80 of a user. Various glove sizes and shoe sizes may be used toproduce embodiments 64, 66 for use.

FIG. 11 is an enlarged view of the microprotrusions 16, which ashereinabove noted, may be coated with botulinum toxin or alternatively,filled with a solution including botulinum toxin.

In this instance, a reservoir 90 may be provided behind themicroprotrusions 16 and covered by a backing 92 for enabling pressure tobe exerted on the reservoir for effecting delivery of the botulinumtoxin from the microprotrusion.

It should be appreciated that the length of the microprotrusions arevaried depending upon the anatomy of the particular tissue beingtargeted by the therapeutic neurotoxin.

Although there has been hereinabove described a specific needlelessmicroprotrusion blastoplast system in accordance with the presentinvention for the purpose of illustrating the manner in which theinvention may be used to advantage, it should be appreciated that theinvention is not limited thereto. That is, the present invention maysuitably comprise, consist of, or consist essentially of the recitedelements. Further, the invention illustratively disclosed hereinsuitably may be practiced in the absence of any element which is notspecifically disclosed herein. Accordingly, any and all modifications,variations or equivalent arrangements which may occur to those skilledin the art, should be considered to be within the scope of the presentinvention as defined in the appended claims.

1. A needleless microprotrusion system for infusion of a medicament intoa patient, the system comprising: a plurality of microprotrusions havinga length sufficient to penetrate a stratum corneum of the patient; achemodenervating agent disposed on surfaces of the microprotrusions; asubstrate for supporting the microprotrusions, said substrate having ashape for conforming to a selected patient body part in order to enableuniform penetration of the microprotrusions into said stratum corneum.2. The system according to claim 1 further comprising two pluralities ofmicroprotrusions, one plurality of microprotrusion dispose on one sideof said substrate and another plurality of microprotrusion disposed onanother side of said substrate.
 3. The system according to claim 2wherein said substrate is sized for positioning within a palm of saidpatient.
 4. The system according to claim 1 wherein said substrate issized and shaped for positioning against a palm and fingers of a user.5. The system according to claim 1 wherein said substrate is sized andshaped for conforming to a patients' armpit.
 6. The system according toclaim 1 wherein said substrate is sized and shaped for positioningagainst a sole of a users' foot.
 7. The system according to claim 1wherein said substrate is sized and shaped for positioning against asole and toes of a users' foot.
 8. The system according to claim 1wherein said substrate is sized and shaped for application to aglabellar region of said patient.
 9. The system according to claim 1further comprising an adhesive disposed on said substrate for temporaryadhering said substrate to a patients' skin.
 10. The system according toclaim 7 further comprising an adhesive disposed on said substrate fortemporary adhering said substrate to a patients' skin.
 11. The systemaccording to one of claims 9 and 10 wherein said adhesive surrounds saidmicroprotrusion.
 12. The system according to one of claims 1, 2, 3, 4,5, 6, 7, 8, 9, and 10 wherein said substrate is flexible.
 13. The systemaccording to one of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 whereinsaid chemodenervating agent is coated on said microprotrusion.
 14. Thesystem according to claim 13 wherein said chemodenervating agentcomprises botulinum toxin.
 15. The system according to one of claims 1,2, 3, 4, 5, 6, 7, 8, 9, and 10 wherein said chemodenervating agent isdisposed within said microprotrusion.
 16. The system according to claim15 wherein said chemodenervating agent comprises botulinum toxin.
 17. Amethod for delivering a medicament to palms of a patient, said methodcomprising: providing a substrate having a shape for conforming to apalm of a patient, said substrate having microprotrusion disposed onopposite sides of said substrate, said microprotrusion having a lengthsufficient to penetrate a stratum corneum of the patients' palm;providing a chemodenervating agent for delivering by saidmicroprotrusion; and instructing said patient to dispose said substratein one palm and press another palm against the substrate in order toeffect simultaneous delivery of said chemodenervating agent into bothpalms.
 18. The method according to claim 17 wherein saidchemodenervating agent comprises botulinum toxin.
 19. The methodaccording to one of claims 17 and 18 further comprises providing aflexible substrate.
 20. The method according to one of claims 17 and 18further comprising coating the microprotrusion with saidchemodenervating agent.
 21. The method according to one of claims 17 and18 further comprising filling the microprotrusions with saidchemodenervating agent.